Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?

Last updated: November 12, 2019
Sponsor: University of Miami
Overall Status: Completed

Phase

2/3

Condition

Dry Eyes

Dry Eye Disease

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT02701764
20160095
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 and 65 years of age

  • undergoing LASIK (unilateral or bilateral procedure).

  • Females of child-bearing age will need a negative urine or serum pregnancy test at thescreening visit.

  • ocular and systemic medication regimen has been stable for 3 months

Exclusion

Exclusion Criteria:

  • Pregnant or lactating, participating in another study with an investigational drugwithin one month prior to screening

  • Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), ortri-cyclic antidepressants

  • have a history of allergic, anaphylactic reaction, or severe systemic response topregabalin or gabapentin

  • use corticosteroids chronically or during the month prior to surgery, or have ahistory of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer).

  • patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis,graft-versus host disease or a collagen vascular disease.

  • Adults unable to consent

  • Individuals who are not yet adults (infants, children, teenagers)

  • Prisoners

Study Design

Total Participants: 43
Study Start date:
July 26, 2016
Estimated Completion Date:
December 01, 2018

Study Description

Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in some patients, they can persist. The investigators believe that in some individuals, dry eye symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The investigators wish to study if a medication, called pregabalin, can protect corneal nerves at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6 months after surgery. This medication has been used in a similar way to reduce the frequency of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied in LASIK surgery.

Connect with a study center

  • Anat Galor

    Miami, Florida 33133
    United States

    Site Not Available

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